Spinal Cord Injury/Damage Clinical Trial
Official title:
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
| NCT number | NCT02031835 |
| Other study ID # | UIoannina612014 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2012 |
| Est. completion date | March 2020 |
| Verified date | November 2020 |
| Source | University of Ioannina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS).
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | March 2020 |
| Est. primary completion date | March 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 88 Years |
| Eligibility | Inclusion Criteria: - SCI - ASIA classification B, C or D - clinical stable Exclusion Criteria: - unstable cardiac conditions - epilepsy - autonomic dysreflexia - significant musculoskeletal problems in lower extremities other than SCI - Parkinson's disease |
| Country | Name | City | State |
|---|---|---|---|
| Greece | University Hospital of Ioannina | Ioannina |
| Lead Sponsor | Collaborator |
|---|---|
| University of Ioannina |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | WISCI II | Change of walking independence at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | ASIA standard neurological classification for spinal cord injury patients working sheet | Change of neurological impairment status at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | Modified Ashworth scale | Change of spasticity of leg muscles at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | WHOQOL-BREF | Change of patients' perspective of life quality at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | 10-item Modified Barthel Index | Change of function at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | DXA scan | Change of BMD of hip and spine at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | Full Body DXA scan | Change of body tissue consistency at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | |
| Secondary | Hematological analysis | Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks |